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Getting Your Product Approved – Regulatory Considerations for the EU and US

When developing a veterinary product for the global market, differences in product categorisation and applicable regulations can be difficult to navigate. The final article in the “From Molecule to Market” series provides an overview of the regulation for animal health products in the European Union (EU) and the United States (US).

Regulatory Agencies

European Union

In the EU there are different agencies responsible for the regulation of veterinary medicinal products, immunologicals, biologicals, feed and feed additives.

The European Medicines Agency (EMA) is the agency of the European Union (EU) which regulates all types of Veterinary Medicinal Products (VMPs). Responsibility for scientific evaluation, supervision and safety monitoring is with the Committee for Medicinal Products for Veterinary Use (CVMP). The CVMP consists of representatives of the individual national EU and EEA (European Economic Area) authorities as well as additional experts and plays an important role during the initial assessment of marketing authorisation applications. After evaluation by CVMP the European Commission (EC) issues the marketing authorisation.

The national competent authorities of the EU Member States regulate the products authorised in the individual countries. For feed and feed additives the European Food Safety Authority (EFSA) is responsible for the scientific assessment. Biozides are regulated by the European Chemical Agency (ECHA). United States In the US, there are three agencies that regulate veterinary products: FDA, USDA, and EPA.

Veterinary drugs are regulated by the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). The Federal Food, Drug, and Cosmetic Act gives FDA its authority to regulate animal drugs. From the Act, regulations are codified in title 21 of the Code of Federal Regulations (21CFR). Guidance documents (GFIs) provide CVM’s current thinking and interpretation of how to comply with the regulations.

Veterinary biologics are regulated by the United States Department of Agriculture Center for Veterinary Biologics (USDA-CVB). The Virus-Serum-Toxin Act gives USDA its authority to regulate animal biologics. From the Act, regulations are codified in title 9 of the CFR (9CFR). Guidance documents (VSMs) provide CVB’s current thinking and interpretation of how to comply with the regulations.

Certain topical veterinary products that kill pests without systemic action are regulated by the Environmental Protection Agency (EPA). This type of product is beyond the scope of this article.

Categorisation of Products

European Union

Before the new Regulation (EU) 2019/6 came into effect, products had been classified either as ‘Veterinary Medicinal Products’ or ‘Immunological Veterinary Medicinal Products’. The new Regulation introduced the definition of biological products and biological substances for the first time. Consequently, a new product categorisation was implemented. Products are therefore now classified as: ‘Veterinary Medicinal Products’ other than biological veterinary medicinal products and ‘Biological Veterinary Medicinal Products’. Biological products are further divided into: ‘Biological Veterinary Medicinal Products’ other than Immunologicals (i.e., Biologicals) and ‘Immunological Veterinary Medicinal Products’.